Human Research Review Committee (HRRC-IRB)

Supported by the Human Research Protections Office

HRRC Home > Forms > Submitting a New Research Study > Expedited Review Research

Expedited Review Research Submissions ("Expedited" simply means that the study will not go to full committee review)

Note: In order to qualify for expedited review, research activities must:

1) Present no more than minimal risk to participants

2) Not involve classified research

3) Involve procedures listed in one or more of the research categories starting on page 2 of the application

1 copy of each of the following documents should be delivered to our office and emailed to hrrc@salud.unm.edu. You can also view/print this checklist from a word document.

Items Required for EVERY Expedited Study - All forms are in MS Word except where noted

ü Application Form

ü Department Review Form - To be completed by head of department submitting the study

ü The following PDF forms must be filled out by every investigator listed on attachment 1, as well as the Principal Investigator

Conflict of Interest Statement for UNM Employees

Conflict of Interest Statement for non-UNM Employees

ü One of the Following:

Investigators Protocol: Guidelines for developing the Protocol
NIH Grant Application (If study is supported by NIH, a copy of the grant application must be submitted)
Cooperative Group Protocol
Sponsor's Protocol (for commercially sponsored studies)

Items Required if applicable to Expedited Study - All forms are in MS Word except where noted

ü Any Applicable Attachments:

	1. Additional Investigators List	8. Request for Waiver of Informed Consent/HIPAA
	2. Studies Involving Minors	9. Studies Involving Use of Medical Devices
	3. Studies Involving Drugs, Biologics, Radiopharmaceuticals	10. Studies Involving Prisoners
	4. Studies Involving Biological Specimens	11. Studies Involving Use of General Clinical Research Center (GCRC)
	5. Studies Involving Exposure to Ionizing Radiation

ü Sponsorship Information Form and if applicable $2,000 Application Fee

ü Consent and/or HIPAA Form

ü Data Safety Monitoring Plan (Required for all GCRC Studies)

ü DHHS approved sample Consent Form

ü Radiation Control Human Uses Subcommittee Approval Letter

ü All Questionnaires, surveys, etc.

ü All recruitment materials and advertisements

ü Investigator's Brochure or device manual (for commercially sponsored studies)

ü Sponsor's non-significant risk determination (if device study and no IDE was submitted to FDA)

Home

School of Medicine

UNM

HSC

Email questions or comments about this website